MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG QUART ARTERIAL FILTER, MODEL HBF 140; FILTER, BLOOD, CPB, ARTERIAL LINE

Model Number HBF-140 J

Device Problems Particulates (1451); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Date 10/05/2012

Event Type  malfunction  

Event Description

On (b)(6) 2012 at the (b)(6) hospital in (b)(6), it was reported that floating red particles were found in two units of the arterial filter quart hbf-140 when the air vent was opened after filling the priming solution.There was no patient involvement.Note: two mdr's will be submitted for this event since it involved two arterial filter quart hbf-140.Mdr # 8010762-2014-00479 was generated for the first unit.(b)(4).

Manufacturer Narrative

(b)(4).Per the complaint closure letter dated march 11, 2013 wherein the investigation results are described, the presence of red particulate matter was due to abrasion of the red stopcock.The root cause was determined to be the combination of heat influence with a burr in the molding tool.The molding tool was polished and the stopcock holder was centered to avoid cutting of the red plastic.(b)(4).

• Brand Name: QUART ARTERIAL FILTER, MODEL HBF 140
• Type of Device: FILTER, BLOOD, CPB, ARTERIAL LINE
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; kehler strasse 31; rastatt, 7643 7; GM 76437
• Manufacturer (Section G): MAQUET CARDIOPULMONARY AG; kehler strasse 31; rastatt, 7643 7; GM 76437
• Manufacturer Contact: tina evancho ; maquet medical system, usa; 45 barbour pond drive; wayne, NJ 07470 ; 9737097265
• MDR Report Key: 4282883
• MDR Text Key: 17994885
• Report Number: 8010762-2014-01076
• Device Sequence Number: 1
• Product Code: DTM
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K001787
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/26/2012

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2013
• Device Model Number: HBF-140 J
• Device Catalogue Number: 70103.1617
• Device Lot Number: 70065653
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2012
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 10/26/2012
• Device Age: 18 MO
• Event Location: Hospital
• Date Report to Manufacturer: 10/26/2012
• Initial Date Manufacturer Received: 10/26/2012
• Initial Date FDA Received: 11/27/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/04/2011
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1